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| RTOG Protocol No: 97-12 | Protocol Status: | |
| Opened: | February 1, 1998 |
| Closed: | October 28, 2002 |
Title: A Phase I Dose Escalation Study of Thoracic Irradiation With Concurrent Chemotherapy for Patients With Limited Small Cell Lung Cancer
Patient Population:
- Histologic or unequivocal cytologic proof of SCLC with measurable or evaluable disease.
- Clinically limited disease with no prior chemotherapy or radiotherapy.
- Absolute granucocytes > 1500, platelets >150,000, bilirubin <1.5 mg/d., creatinine <1.5 mg/d.
- KPS >70, age >18.
- No pericardial or pleural effusion on CXR regardless of cytology.
- No previous (within 2 years) or concurrent malignancy except for non-melanotic skin cancer or carcinoma in situ of cervix.
- Signed study-specific consent form.
Objectives:
1. To find the maximum tolerated dose of thoracic radiation using an accelerated boost with concurrent chemotherapy.
2. To increase local control by increased radiation dose in thorax to improve survival.
3. To reduce toxicity to the esophagus and/or the lung.
4. To monitor baseline and followup neuropsychological function.
| Schema: |
R
E
G
I
S
T
E
R |
Arm 1: | Large field 36 Gy, 1.8 Gy/fx/D/5 days/4 weeks, |
| (Closed | boost 1.8 Gy/D x 2 days, then BID x last 3 days. |
| 6/23/98) | Total dose: 50.4 Gy |
| Arm 5: | Large field 36 Gy, 1.8 Gy/fx/D/5 days/4 weeks, |
| (Closed | boost 1.8 Gy/D x 2 days, then BID x last 3 days. |
| 3/19/99) | Total dose: 50.4 Gy. |
| Arm 2: | Large field 36 Gy, 1.8 Gy/fx/D/5 days/4 weeks, |
| (Closed | boost 1.8 Gy BID x last 5 days. |
| 9/24/99) | Total dose: 54.0 Gy |
| Arm 3: | Large field 32.4 Gy, 1.8 Gy/fx/D/5 days x 18 fx, |
| (Closed | boost just in pm @ 1.8 Gy/fx on days 19 & 20 (use ap/pa fields in am @ 1.8 Gy/fx), |
| 5/5/00) | then boost 1.8 Gy BID x last 5 days. |
| Total dose: 57.6 Gy |
| Arm 4: | Large field 28.8 Gy; 1.8 Gy/fx/5 days x 16 fx, |
| (Closed | boost just in pm @ 1.8 Gy/fx on days 17-20 (use ap/pa fields in am @ 1.8 Gy/fx), |
| 5/4/01) | then boost 1.8 Gy BID x last 5 days. |
| Total dose: 61.2 Gy |
| Arm 6: | Large field 25.2 Gy; 1.8 Gy/fx/D/5 days x 14 fx, |
| (Closed | boost just in pm @ 1.8 Gy/fx on days 15-20 (use ap/pa fields in am @ 1.8 Gy/fx), |
| 1/11/02) | then boost @ 1.8 Gy BID x last 5 days. |
| Total dose: 64.8 Gy |
| Chemotherapy | Chemotherapy will be started on day 1 of thoracic radiotherapy
(+/-24 hours)
Cisplatin (DDP), 60 mg/M2 i.v. day 1.
Etoposide (VP-16), 120 mg/M2 i.v. day 1
Etoposide (VP-16), 240 mg/M2 p.o. per day on days 2 and 3
Repeat cycle every 3 weeks x 4 cycles.
G-CSF to be administered as needed. |
| Study Chairs: | Ritsuko Komaki, M.D. (Radiation Oncology) | Patients Entered as of: |
| David Ettinger, M.D. (Medical Oncology) | 10/28/02 | 64 |
1. Reference: Komaki R, et al. Phase I Dose-Escalation Study of Thoracic Irradiation with Concurrent Chemotherapy for Patients with Limited Small Cell Lung Cancer (LSCLC). Radiation Therapy Oncology Group (RTOG) Protocol 97-12. Proceeding from Am Soc Clin Oncol (ASCO), Chicago, IL. J Clin Oncol 22:631, 2003.
Abstract: Accelerated RT was shown to improve local control (LC) and survival among pts with LSCLC, but local failure was still unacceptably high. To increase LC and survival, a multi-institutional phase I radiation dose-escalation study was undertaken by the RTOG. Previously untreated, pathologically confirmed SCLC pts with limited stage and KPS > 70 were enrolled between 2/98 and 1/02. Pts originally received cisplatin (P), 60 mg/M2 IV and etoposide (E) 120 mg/M2 IV days 1-3, repeated every 3 wks x 4 cycles with concurrent thoracic radiation therapy (TRT) during the first 2 cycles of PE. TRT was given 1.8 Gy daily to 36 Gy followed by a small boost field encompassing only the gross disease. Boost TRT was delivered with escalations of 1.8 Gy twice daily (Bid) during the final days to establish the maximum tolerated dose (MTD). The first arm used a boost of 3 Bid Fx 1.8 Gy for a TD of 50.4 Gy. Escalations of Bid TRT during the last 5, 7, 9, and 11 days permitted TDs of 54 Gy 57.6 Gy 61.2 Gy and 64.8 Gy , all in a total time of 5 wks. A 50% rate of acute Gr 3 or 4 acute esophagitis was considered dose-limiting. 64 pts were enrolled: 2 of the first 8 receiving 50.4 Gy developed Gr 3 acute esophagitis. Dose of E was changed to 240 mg/M2 PO on days 2 & 3 with same TRT dose of 50.4 Gy: 10 pts were treated with acceptable toxicity. Progressive dose escalations were possible until the 64.8 Gy arm when 3 of 8 pts (which exceeded the stopping rules for the trial) had Gr 3 acute esophagitis. Therefore, the MTD was determined to be 61.2 Gy, in 34 Fx of 1.8 Gy when given concurrently with this regimen of PE, which has been proposed as a phase II study through RTOG.
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