| CTRI Number |
CTRI/2012/01/002369 [Registered on: 24/01/2012] Trial Registered Retrospectively |
| Last Modified On: |
23/01/2012 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Radiation Therapy |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A Randomized Trial comparing 6 ½ weeks radiotherapy treatment (66 Grey total radiation dose) combined with chemotherapy versus 5 weeks accelerated radiotherapy alone (67.5 Grey) in Stage III/IV (locally advanced ) Oropharyngeal cancers. |
|
Scientific Title of Study
|
A Randomized trial comparing Accelerated Radiotherapy with Concomitant Boost schedule versus Concurrent Conventional Chemo-radiation in locally Advanced Oropharyngeal cancers. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Prof Sushmita Ghoshal |
| Designation |
Professor |
| Affiliation |
PGIMER |
| Address |
Department of Radiotherapy,
PGIMER,
Sector 12,
chandigarh-160012
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9914209394 |
| Fax |
|
| Email |
rtsushmita@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr ANUPAM RISHI |
| Designation |
Senoir Resident |
| Affiliation |
PGIMER |
| Address |
Department of Radiotherapy,
PGIMER,
Sector 12,
chandigarh-160012
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9855900732 |
| Fax |
|
| Email |
anupamrishi@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr ANUPAM RISHI |
| Designation |
Senoir Resident |
| Affiliation |
PGIMER |
| Address |
Department of Radiotherapy,
PGIMER,
Sector 12,
chandigarh-160012
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9855900732 |
| Fax |
|
| Email |
anupamrishi@rediffmail.com |
|
|
Source of Monetary or Material Support
|
| PGIMER,
Sector 12,
chandigarh-160012 |
|
|
Primary Sponsor
|
| Name |
PGIMER |
| Address |
Sector 12,
chandigarh-160012 |
| Type of Sponsor |
Research institution |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Prof Sushmita Ghoshal |
Room No 6 (Head & Neck Cancers), department of radiotherapy, PGIMER |
Sector 12,
chandigarh-160012
Chandigarh
CHANDIGARH |
9914209394
rtsushmita@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| PGIMER Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
CANCER, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
chemotherapy
radiotherapy |
66Gy/33 fractions/6 1/2 weeks with Concurrent cisplatin 100 mg per meter sq BSA in Chemoradiation arm only on Days 1, 22 and 43 of treatment. |
| Intervention |
radiotherapy,
|
radiation: 67.5 Gy/25 fractions/5weeks in Concomitant boost Arm.
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1. Biopsy proven cases of squamous cell carcinoma of oropharynx with no prior cancer directed treatment.
2. Tumor staged as III/IV as per the AJCC staging system.
3. Patient with a Karnofsky performance score (10) of 70 and above.
4. Patient who sign the informed consent and are ready to be on follow up as required.
|
|
| ExclusionCriteria |
| Details |
1. Age < 18 years or >70 years
2. Pregnant women
3. Prior invasive malignancy.
4. Patients with simultaneous primaries or bilateral tumors are excluded
5. N3 nodal status.
6. Uncontrolled co morbid conditions.
|
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
locoregional control,
disease free survival, |
6 MONTHS |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
acute and late toxicity,
Quality of life |
6 MONTHS |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
Final Enrollment numbers achieved (Total)= ""
Final Enrollment numbers achieved (India)="" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
19/11/2009 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="3"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Presented the premature results in North Zone Association of radiation oncology of india (NZAROI) in oct 2010 at Chandigarh |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Most of the indian patients are nutritionally compromised and are not able to tolerate the concurrent chemoradiation (current standard of care) along with radiation and experience severe toxicity leading to incomplete termination of the treatment (incomplete treatment) which results in poor disease control and recurrence. Concomitant boost radiotherapy is a novel form of altered fractionation scheme which has been well tested in RCTs giving superior results over conventional fractionation and a lesser toxicity than concurrent chemoradiation with better patient tolerance and compliance. There is a lack of RCT between these two treatment modalities in literature. Considering our indian patients, the result of this trial may guide the clinicians of this institute and elsewhere to choose between these two modality with greater confidence and an option of concomitant boost radiotherapy can always be offered to suitable patients omitting the added toxicity (acute and late) of the concurrent chemotherapy. |