CALGB 30610/RTOG 0538: Phase III Comparison of Thoracic Radiotherapy Regimens in Patients with Limited Small Cell Lung Cancer also Receiving Cisplatin and Etoposide

Study ID
STU 072010-049

Cancer Related
Yes

Healthy Volunteers
No

Study Sites

Contact
Suprabha Pulipparacharuvil
214-633-1752
suprabha.pulipparacharuvil@utsouthwestern.edu

Principal Investigator
Hak Choy

Summary

This is a multi-center randomized phase iii comparison study of thoracic radiotherapy regimens in patients with limited small cell lung cancer who are also receiving cisplatin or carboplatin and etoposide. about 10 patients will participate in the study at uT Southwestern, Parkland Health Hospital System, and Richardson Regional Cancer Center.

Treatment of Group 1 and 2 are all a part of standard of care: radiation therapy with chemotherapy (cisplatin or carboplatin and etoposide). Timing, frequency, and time frame of radiation therapy differs between the two groups. Group 1 radiation therapy treatment is standard, whereas Group 2 radiation treatment is given at higher doses, different frequencies, and longer period of time. This study will determine which regime is more effective and safer when treating small cell lung cancer.

Defining an optimal TRT regimen in LSCLC remains critical and will have a major impact on clinical practice. intergroup study 0096 clearly established that improving the efficacy of thoracic radiotherapy can significantly impact survival in patients with LSCLC. Given the reluctance for practitioners to adopt 45 GY BiD TRT, the validity of this regimen needs to be assessed in the context of TRT regimens that have higher predicted biologic efficacy and may have improved tolerability and acceptance. Superior outcomes on an experimental arm would lead to establishing a change in the standard of care for patients with LSCLC. Conversely, if the best outcomes were observed with accelerated 45 Gy BiD TRT, then the results of this study would provide convincing and definitive evidence for practitioners to adopt this regimen.

as of September 15, 2014, the protocol was amended to allow substitution of carboplatin for cisplatin at the discretion of the treating physician, and the choice of chemotherapy will be used as a stratification factor. it has become clear during the past several years that carboplatin and etoposide chemotherapy is a commonly used regimen for patients with limited small cell lung cancer, and several investigators have requested that a carboplatin based regimen be allowed. Though the choice of chemotherapy has been widely discussed, there is not clear data
that supports the use of cisplatin over carboplatin in small cell lung cancer. a study randomizing patients with small cell lung cancer to receive either cisplatin or carboplatin (with etoposide), conducted by the Hellenic Cooperative oncology Group, did not demonstrate a difference in response rates or survival with either regimen (99). Moreover, phase ii CaLGB studies employing a carboplatin and etoposide backbone concurrent with high dose (7000
cGy ) thoracic radiotherapy have accrued well.

Participant Eligibility


* Individuals 18 years or older

* ECOG Performance Status 0-2

* Histologically or cytologically documented small cell lung cancer

* Patients may have received one and only one cycle of chemotherapy prior to enrolling

* Measurable disease:
o Lesions that can be accurately measured in at least one dimension (longest diameter to be recorded) as >= 2 cm with conventional techniques or as >= 1 cm with spiral CT scan

* Non-Measurable Disease: All other lesions, including small lesions (longest diameter < 20 mm with conventional techniques or < 10 mm with spiral CT scan) and truly nonmeasurable lesions. Lesions that are considered non-measurable include the following:
o Bone lesions
o Leptomeningeal disease
o Ascites
o Pleural/pericardial effusion
o Inflammatory breast disease
o Lymphangitis cutis/pulmonis
o Abdominal masses that are not confirmed and followed by imaging techniques
o Cystic lesions

* Required Initial Laboratory Values
o Granulocytes >= 1,500/[MICRO-SYMBOL]l
o Platelet Count >= 100,000/[MICRO-SYMBOL]l
o Total Bilirubin <= 1.5 x ULN
o AST (SGOT) <= 2.0 x ULN
o Serum Creatinine <= 1.5 x ULN
OR
o Calculated Creatinine Clearance >= 70 ml/min