NCI Community Oncology Research Program - Kansas City (NCORP-KC)
NCI Community Oncology Research Program - Kansas City (NCORP-KC)




NCI Community Oncology Research Program Protocol Summary

CALGB 30610 - "Phase III Comparison of Thoracic Radiotherapy Regimens in Patients with Limited Small Cell Lung Cancer also Receiving Cisplatin and Etoposide"

The summary below serves as a brief review of the treatment plan and eligibility for the protocol.


This summary is not intended to be used in place of the full eligibility & treatment information in the protocol.
 

Please follow the "Full Protocol" link or contact NCORP-KC for complete protocol information.



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Lung Clinical Trial

CANCER TYPE: Small Cell
RESEARCH BASE: CALGB 30610
NCT NUMBER:
HIPPA FORM: DOWNLOAD HIPPA FORM

Consent Form: VIEW CONSENT FORM

BRIEF DESCRIPTION

SC (max 1 hemithorax w/regional LN mets), <1 prior chemo cycle (must incl Cisplatin & Etoposide), no prior RT or other chemo for SC/mediastinal or thoracic RT/complete resec; Comparison of 2 thoracic RT regimens + Cisplatin & Etoposide



NOTES


Patients registered to CALGB 30610 prior to the start of cycle 1 protocol treatment will start therapy within 7 days of registration.

 

Treatment Plan (Supplied Drug: None)

 

RANDOMIZATION: PART II (PART I was closed to further accrual on March 10, 2013)

Arm A

RT: 45Gy, BID (1.5Gy/fx), starting Day 1 of Cycle 1 or 2, QD (Mon-Fri) x 3 wks

Cisplatin: 80mg/m2, IV, Day 1, q 21 days, x 4 cycles

or

Carboplatin:  AUC 5, IV, Days 1, 2 & 3, q 21 days

Etoposide: 100mg/m2, IV, Days 1, 2 & 3, q 21 days

Arm B

RT: 70Gy, QD (2.0Gy/fx), starting Day 1 of Cycle 1 or 2, QD (Mon-Fri) x 7 wks

Cisplatin: 80mg/m2, IV, Day 1, q 21 days, x 4 cycles

or

Carboplatin:  AUC 5, IV, Days 1, 2 & 3, q 21 days

Etoposide: 100mg/m2, IV, Days 1, 2 & 3, q 21 days

 

Prophylactic cranial RT should be offered to all pts w/complete or near CR (see protocol for details).



ELIGIBILITY

  • Histol- or cytol-documented small cell lung cancer.

  • Limited stage disease (restricted to 1 hemithorax w/regional LN mets, including ipsilateral hilar, ipsilateral & contralateral mediastinal, & ipsilateral supraclavicular lymph nodes). NO involvement of contralateral hilar or supraclavicular LNs are allowed. NO pleural effusions visible on plain chest xrays (whether cytologically positive or not), unless pt has negative thoracentesis. NO cytologically positive pleural or pericardial fluid (regardless of appearance on plain xray).

  • Must have meas disease (lesions that can be accurately meas in >1 dimension [longest to be recorded] as >2cm w/conventional techniques or >1cm w/spiral CT.

  • Patients may have received one and only one cycle of chemotherapy prior to enrolling on CALGB 30610, which must have included carboplatin or cisplatin and etoposide. If a patient has had one cycle of cisplatin (or carboplatin)/etoposide prior to registration, the patient must have had all of the prior to registration tests outlined in Section 7.0 prior to starting their first cycle of chemotherapy. Additionally, these patients also must have met all of the eligibility criteria in Section 4.0 prior to receiving the first cycle of chemotherapy. Registration to CALGB 30610 must take place within 7-21 days after the start of the non-protocol therapy. Failing to do all of the above will make the patient NOT eligible for CALGB 30610.

  • No prior radiotherapy or chemo for SC lung cancer (except the chemo described above).

  • No prior mediastinal or thoracic RT.

  • No complete surgical resection of disease.

  • Age >18.

  • ECOG perf status 0-2.

  • No pregnant or nursing women.

  • Granulocytes >1500/uL, platelets >100,000/uL, total bili <1.5x ULN, SGOT <2.0x ULN, serum creat <1.5x ULN or calc CrCl >70ml/min.

  • PRESTUDY REQUIREMENTS:

    Within 16 days pre-regist: All bloodwork; H&P

    Within 28 days pre-regist: Any xray, scan, or US used for tumor msmt

    Within 42 days pre-regist: Any baseline exams used for screening; any xray, scan, or US of uninvolved organs not used for tumor msmt

    Pts registered after 1 cycle of therapy must have all tests done at timepoints above, but must be done "b/f 1st cycle of chemo", rather than "pre-regist".

    • PE, pulse, BP, ht, wt, BSA, perf status

    • Tumor msmts

    • CBC/diff/platelets

    • Bili, LDH, SGOT, creat, BUN, Mg, Na, Ca

    • DLCO, FEV-1, FVC (may be done prior to Cycle 2 if pt received Cycle 1 pre-regist)

    • Pregnancy test (if applicable)

    • Spiral chest CT*

    • Spiral abdominal CT*

    • Bone or PET scan

    • MRI (or CT) brain

    • QOL asmts**

    • Plasma collection (correlative science studies)**#

    * <5mm thick sections - see protocol for details.

    ** With pt's consent.

    # At baseline & other timepoints. Two 10-ml purple-top tubes of whole blood.

  • Signed informed consent.






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